ABOUT THIS STUDY
FOR MORE INFORMATION
Contact a representative by phone, email, or visiting the study website. Please see the references below:
Pfizer Clinical Trials Contact Center
1-800-718-1021
- Diagnosis of acromegaly
- Received previous radiation and/or surgical treatment for their GH (Growth Hormone) producing pituitary adenoma and have required medical therapy due to failure to normalize GH (Growth Hormone) and/or IGF-I as a result of their primary treatment
- Patients that been receiving Sandostatin LAR for a minimum of 6 months prior to enrollment
- Presence of other conditions that may result in abnormal GH (Growth Hormone) and/or
IGF-I concentrations
- Patients on current medical therapy other than Sandostatin LAR
- AST/ALT >= 3xULN (upper limits of normal)
- Pituitary adenoma within 3mm of optic chiasm confirmed by recent MRI
- Visual field defects (except post-surgical stable residual defects)
- Unable to self administer drug
- Radiotherapy within 12 months of entering the study
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Descriptive Information | ||||
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Brief Title ICMJE | Pegvisomant And Sandostatin LAR Combination Study | |||
Official Title ICMJE | A Randomized, Parallel Group, Three-Arm Study To Evaluate Treatment With A Combination Of Pegvisomant Plus Sandostatin Lar, Pegvisomant (Alone), And Sandostatin Lar (Alone) In Patients With Acromegaly | |||
Brief Summary | The purpose of this study is to compare the safety and tolerability of combination therapy with Sandostatin LAR plus Pegvisomant to that of Sandostatin LAR alone or Pegvisomant alone. | |||
Detailed Description | Not Provided | |||
Study Type ICMJE | Interventional | |||
Study Phase ICMJE | Phase 4 | |||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: None (Open Label) Primary Purpose: Treatment | |||
Condition ICMJE | Acromegaly | |||
Intervention ICMJE |
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Study Arms ICMJE | Not Provided | |||
Publications * | Not Provided | |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. | ||||
Recruitment Information | ||||
Recruitment Status ICMJE | Completed | |||
Enrollment ICMJE | 75 | |||
Original Enrollment ICMJE | Not Provided | |||
Actual Study Completion Date ICMJE | May 2006 | |||
Primary Completion Date | Not Provided | |||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years and older (Adult, Older Adult) | |||
Accepts Healthy Volunteers ICMJE | No | |||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries ICMJE | Australia, Brazil, Canada, France, Germany, Italy, Mexico, Netherlands, Norway, Spain, United Kingdom, United States | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number ICMJE | NCT00068029 | |||
Other Study ID Numbers ICMJE | PEGA-0435-005 A6291006 | |||
Has Data Monitoring Committee | Not Provided | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement ICMJE | Not Provided | |||
Responsible Party | Not Provided | |||
Study Sponsor ICMJE | Pfizer | |||
Collaborators ICMJE | Not Provided | |||
Investigators ICMJE |
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PRS Account | Pfizer | |||
Verification Date | April 2008 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |